Shots:

• The BLA for teplizumab to delay or prevention of clinical T1D in at-risk individuals has been filed to the US FDA. The FDA has also granted Provention's request for Priority Review and assigned anticipated PDUFA date as Jul 02- 2021
• The company is actively working with the FDA to support their review while planning to launch the therapy in Q3’21
• Teplizumab is an investigational anti-CD3 mAb and has previously received the US FDA’s BT designation. If approved- teplizumab will be the first disease-modifying therapy for T1D

 ­ Ref: PRNewswire | Image: ProventionBio